Dissection and ligation cartridge

ABSTRACT

Cartridges and methods for ligation or dissection and ligation of tubular tissue structures are described. The cartridges and methods provide a means for efficient dissection and application of one or more ligatures by a single user using a single cartridge resulting in effective closure of a vessel or other tubular tissue structure by placement of a ligature at the desired location resulting in the desired tissue margin or stump.

PRIOR APPLICATIONS

This is a continuation application of U.S. patent application Ser. No.16/349,546 filed on May 13, 2019 which is a U.S. National StageApplication under 35 U.S.C. § 371 of International Application No.PCT/US2017/061538, filed on Nov. 14, 2017, which claims priority to U.S.Provisional Application No. 62/421,874 filed Nov. 14, 2016, the entirecontent of each of which is incorporated by reference into the DetailedDescription herein.

BACKGROUND

Modern surgical techniques and emergency medicine often require thedissection and ligation of vessels and other tubular tissue structures.Current techniques for tubular tissue ligation involve clamping of atubular tissue structure, followed by placement of a clip or staplehaving a pair of legs connected at their proximal ends that are squeezedaround the vessel or tubular tissue structure flattening it. Properapplication of such staples and clips requires technical expertise andit is easy to over- or under-tighten them. Over-tightening can lead totissue damage and necrosis and under-tightening often results inleakage. In some cases, the legs of a clip or staple may not be squeezedtogether sufficiently or may separate following application resulting ininsufficient ligation of a vessel or other tubular tissue structureleading to leakage or blood loss. Frequently, the tissue structure beingligated is inflamed such that the wall thickness is inconsistent, andthe tissue is fragile making effective application of staples and clipswithout damaging the tissue a significant challenge. Adverse events fromthe use of clips and staples further include perforation by staples andinjury from clips and staples that are left in the body. In addition, itis very difficult to apply the clip or staple at the proper angle to thetubular suture and the size of a clip or staple is often not wellmatched to the size of the tubular structure being ligated.

The gold standard for tubular tissue ligation involves applying a sutureor ligature having a knot that is tightened around the vessel or tubularstructure. The knots may be placed too far or not far enough from thedissection site resulting in a stump that is too long increasing therisk of infection or too short increasing the risk of leakage.

Knots may be tied manually or by use of a device that applies andtightens the knot, and may involve tying two or more knots for eachdissected structure, one knot at a time. This is a slow process thatrequires significant skill. Some ligature procedures require one personto manipulate the ligature loop while another person manipulates atissue grasping instrument. In addition, surgery often has spaceconstraints, making it very difficult to effectively ligate a tissuestructure when the process requires more than one set of hands.

In most tubular tissue ligation, it is important to maintain a stump or“tissue margin” adjacent the dissection site. Such a tissue marginensures that even if there is some physical stress induced at the site,the ligated ends of the tissue will not pull through the tightenedsuture loop. In currently available tissue ligation devices, improperplacement of the ligating loop and knot often occurs frequently due tothe inability to stabilize the tissue and the loop, resulting inslippage.

In addition, some tubular tissue structures are smaller than others, andhence a device for tissue ligation must be able to accommodate bothlarge and small tubular structures and be able to ligate a tubulartissue structure that has a variable wall thinness over the section tobe ligated with the proper amount of tension to make a knot with theright degree of tightness.

Accordingly, there remains a need for an improved device and method forligation of tubular tissue structures. The present invention addressesthis need.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic depiction of an exemplary tubular structure thathas been dissected with ligature knots applied and tightened at aprescribed distance from each of the dissected ends creating a stumpaccording to certain embodiments of the invention.

FIG. 2 provides a diagram that shows the relationship of the size of theligature and the size of the tubular structure to the angle α (of theslanted edge of the cartridge relative to the longitudinal axis of thecartridge) according to certain embodiments of the invention.

FIG. 3 is a schematic depiction of an exemplary cartridge that has aslanted edge at the distal end, which may be an arch as shown in thefigure according to certain embodiments of the invention.

FIG. 4 is a schematic depiction of a single barrel cartridge placedaround the mid longitudinal axis of a grasping or clamping instrumentwhich has compression members or jaws at the distal end according tocertain embodiments of the invention.

FIG. 5 is a schematic depiction of two independent grasping or clampinginstruments, both with distal jaws clamping a tubular structure, andwith a single barrel cartridge in a proximal locked position placedaround the mid longitudinal axis of the instrument, and an independentcutting implement (scalpel) according to certain embodiments of theinvention.

FIG. 6 is a schematic depiction of two independent grasping or clampinginstruments, both with distal jaws clamping a tubular structure, and onewith a single barrel cartridge in a distal unlocked position accordingto certain embodiments of the invention.

FIG. 7 is a schematic depiction of a double barrel cartridge whichincludes a slot or guide for moving a cutting implement and a cuttingimplement that has been engaged and moved to the distal end of thecartridge according to certain embodiments of the invention.

FIG. 8A is a schematic depiction of an elongated cartridge, with agrasping or clamping implement at the distal end that is clamping atubular tissue structure according to certain embodiments of theinvention.

FIG. 8B is a schematic depiction of the distal end of a cartridgeshowing the jaws of a grasping or clamping implement clamping a tubularstructure and the presence of ligature loops in a groove at the distalend of the cartridge according to certain embodiments of the invention.

FIG. 8C is a schematic depiction of the distal end of a cartridgeshowing the jaws of a grasping or clamping implement clamping a tubularstructure and a ligature loop which has been moved over the end of thejaws and positioned around the dissected end of a tubular structureaccording to certain embodiments of the invention.

FIG. 9 is a schematic of the jaws of an elongated cartridge grasping orclamping a polyp within a tubular structure according to certainembodiments of the invention.

FIG. 10A is a schematic depiction of a device useful for insertion intoa trocar for dissection and ligation during laparoscopic surgery. Thedevice has an elongated cartridge with a clamping implement at thedistal end attached to a handle which has a handle trigger or actuationengager linked to an actuation mechanism according to certainembodiments of the invention.

FIG. 10B is a schematic depiction of an exemplary handle attached to anelongated cartridge. The handle has an internal actuation mechanismlinked to a spring and a handle trigger or actuation engager accordingto certain embodiments of the invention.

FIG. 11A is a schematic depiction of the distal end of an internalcartridge showing multiple ligature loops pre-positioned in thecartridge and each having a partially slidable knot. The cartridge alsohas a central slot or guide for a cutting implement according to certainembodiments of the invention.

FIG. 11B is a schematic depiction of the distal end of an externalcartridge showing the jaws of a grasping or clamping implement clampinga tubular tissue structure with multiple ligature loops pre-positionedin a groove at the distal end of the cartridge according to certainembodiments of the invention.

FIG. 11C is a schematic depiction of the distal end of an externalcartridge showing the jaws of a grasping or clamping implement clampinga dissected tubular tissue structure with a single ligature loop with apartially slidable knot pre-positioned adjacent the end of the dissectedtubular structure. The figure also shows a knot holder and an exemplarytensioner mechanism comprising a spring according to certain embodimentsof the invention.

FIG. 11D is a schematic depiction of the distal end of an externalcartridge showing the tensioner mechanism, the partially slidable knotof a ligature loop, and a knot holder for holding ligature loops beforethey are released according to certain embodiments of the invention.

FIG. 11E is a schematic depiction of the distal end of an externalcartridge with multiple ligature loops pre-positioned in a groove at thedistal end of the cartridge. An exemplary blade having a serratedcutting edge directed distally is positioned to move forward and cut thetubular tissue structure according to certain embodiments of theinvention.

FIG. 12A is a schematic depiction of an internal cartridge showing awing at the distal end, multiple ligatures each having a partiallyslidable knot and a proximal ligature tail; and a blade, knife or othercutting implement in a central slot or guide of the cartridge accordingto certain embodiments of the invention.

FIG. 12B is a schematic depiction of an internal cartridge housed in asleeve showing a distal grasping or clamping element with oppositelyopposed jaws clamping a tubular tissue structure and the position of aligature loop on the outside of the cartridge according to certainembodiments of the invention.

FIG. 12C is a schematic depiction of the distal end of an internalcartridge showing a grasping or clamping element with oppositely opposedjaws clamping a tubular tissue structure and the position of a ligatureloop on the top outside of the distal end of the cartridge according tocertain embodiments of the invention.

FIG. 12D is a schematic depiction of the distal end of an internalcartridge showing a grasping or clamping element with oppositely opposedjaws clamping a dissected tubular tissue structure, that has beendissected by a blade slidably disposed in a central slot or guide of thecartridge. The figure also shows ligature loops having partiallytightened slidable knots positioned on the outside of the internalcartridge with wings released such that they can be pulled over thedissected ends of the tubular tissue structure to tighten the knotsaccording to certain embodiments of the invention.

FIG. 13 is a schematic depiction of the distal end of a cartridgeshowing a grasping or clamping element with oppositely opposed jawsadjacent a tubular tissue structure wherein the grasping or clampingimplement has an articulating clamp head, wherein the jaws can berotated to be at the optimal angle for dissection and ligating of atubular structure according to certain embodiments of the invention.

The drawings are not intended to be limiting in any way, and it iscontemplated that various embodiments of the invention may be carriedout in a variety of other ways, including those not necessarily depictedin the drawings. The accompanying drawings incorporated in and forming apart of the specification illustrate several aspects of the presentinvention, and together with the description serve to explain theprinciples of the invention; it being understood, however, that thisinvention is not limited to the precise arrangements shown.

DETAILED DESCRIPTION

The following description of certain examples of the technology shouldnot be used to limit its scope. Other examples, features, aspects,embodiments, and advantages of the technology will become apparent tothose skilled in the art from the following description, which is by wayof illustration, one of the best modes contemplated for carrying out thetechnology. As will be realized, the technology described herein iscapable of other different and obvious aspects, all without departingfrom the technology. Accordingly, the drawings and descriptions shouldbe regarded as illustrative in nature and not restrictive.

It should therefore be understood that any one or more of the teachings,expressions, embodiments, examples, etc. described herein may becombined with any one or more of the other teachings, expressions,embodiments, examples, etc. that are described herein. Thefollowing-described teachings, expressions, embodiments, examples, etc.should therefore not be viewed in isolation relative to each other.Various suitable ways in which the teachings herein may be combined willbe readily apparent to those of ordinary skill in the art in view of theteachings herein. Such modifications and variations are intended to beincluded within the scope of the claims.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which the invention pertains. Although other methods andmaterials similar, or equivalent, to those described herein can be usedin the practice of the present invention, the preferred materials andmethods are described herein. Other features and advantages of theinvention will be apparent from the following detailed description, andfrom the claims.

Definitions

In describing and claiming the present invention, the followingterminology will be used in accordance with the definitions set outbelow.

The term “comprises”, and grammatical equivalents thereof are usedherein to mean that, in addition to the features specificallyidentified, other features are optionally present. For example, acomposition or device “comprising” (or “which comprises”) components A,B and C can contain only components A, B and C, or can contain not onlycomponents A, B and C but also one or more other components. The terms“consisting essentially of” and grammatical equivalents thereof are usedherein to mean that, in addition to the features specificallyidentified, other features may be present which do not materially alterthe claimed invention.

The term “at least” followed by a number is used herein to denote thestart of a range beginning with that number (which may be a range havingan upper limit or no upper limit, depending on the variable beingdefined). The term “at most” followed by a number is used herein todenote the end of a range ending with that number (which may be a rangehaving 1 or 0 as its lower limit or a range having no lower limit,depending upon the variable being defined). When a range is given as “(afirst number) to (a second number)” or “(a first number)−(a secondnumber)”, this means a range whose lower limit is the first number andwhose upper limit is the second number. The terms “plural”, “multiple”,“plurality” and “multiplicity” are used herein to denote two or morethan two.

Where reference is made herein to “a” or “an” feature, this includes thepossibility that there are two or more such features (except where thecontext excludes that possibility). Where reference is made herein totwo or more features, this includes the possibility that the two or morefeatures are replaced by a lesser number or greater number of featuresproviding the same function, except where the context excludes thatpossibility. The numbers given herein should be construed with thelatitude appropriate to their context and expression; for example, eachnumber is subject to variation which depends on the accuracy with whichit can be measured by methods conventionally used by those skilled inthe art.

The terms “ligature end” or “knot ear” are used herein with reference tothe length of ligature that extends beyond a ligature knot. The ligatureend or knot ear may be 3 mm or longer, from 2-4 mm, from 2-5 mm, from3-6 mm, 1 mm, 2 mm, 3 mm, 4 mm or 5 mm for a knot ear that is pre-set ona partially tightened slidable knot. Following tightening of a partiallytightened slidable knot 26, the ligature tail 28 may be cut resulting ina knot ear 4 having a length of 3 mm or longer, from 2-4 mm, from 2-5mm, from 3-6 mm, 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm,or 10 mm.

As used herein the term “occlusion”, is used with reference to theblockage or closing of a tubular tissue structure.

The term “stump” is used herein with reference to the section of atubular tissue structure 1 between a tightened ligature knot and thedissected end of the tissue structure.

The terms “stump length” and “length of the stump” are used herein withreference to the distance between the ligature knot and the dissectedend of the tubular tissue structure. A stump length may be from about 1mm to about 15 mm, from about 1 mm to about 12 mm, from about 1 mm toabout 10 mm, from about 2 mm to about 8 mm, from about 3 mm to about 7mm, from about 4 mm to about 6 mm, from about 5 mm to about 7 mm, 3-4mm, 4-5 mm, 5-6 mm, 6-7 mm, 7-8 mm, 8-9 mm, 9-10 mm, 1 mm, 2 mm, 3 mm, 4mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, 13 mm, 14 mm, or15 mm. The stump may be longer on one side than the other.

The terms “tubular structure” and “tubular tissue structure” are usedherein with reference to a structure in the body of a human or animal,e.g., a tissue such as an organ or vessel that can be ligated using thecartridges and methods disclosed herein.

This specification incorporates by reference all documents referred toherein and all documents filed concurrently with this specification orfiled previously in connection with this application, including but notlimited to such documents which are open to public inspection with thisspecification.

Overview

The cartridges and methods disclosed herein allow a single person toeffectively accomplish ligation of a tubular tissue structure with thedesired tissue margin (stump length) in a fraction of the time requiredfor manual ligation. The cartridges and methods can accommodate tubulartissue structures with a wide variation in diameter and wall thicknessand do not depend upon the skill of the user. The jaws can accommodate atubular tissue structure with a diameter of from 2-30 mm.

Use cases for the cartridges and methods disclosed herein include, forexample, emergency medicine, human and veterinary surgery includingminimally-invasive surgery, general surgery, endoscopy and laparoscopy,and robotic surgery, as further described below.

Products routinely used for ligation in laparoscopic, minimally-invasiveand robotic surgical procedures that are staples, clips, and surgicalknots, each of which is deficient in one or more ways.

Surgical closure with sutures (loop and knot) is the “gold standard” forsurgical ligation. Currently available options include manual tying of aknot (essentially “sewing”), which requires several manual actions. Theprocedure is slow and requires a high skill level for the surgeon and atrained assistant. A device, the Endoloop® is used for ligation inlaparoscopic procedures. It consists of a single long ligature in aplastic tube that is a ligature loop with a knot. The technique ofdeploying an Endoloop® involves opening the loop, then maneuvering itaround the severed tubular tissue structure to be ligated. This involvesskill because the Endoloop® is floppy and complex manual actions arerequired to get it in a good position before it is tightened. Theprocess is slow with multiple instruments and requires a skilled surgeonand an assistant. In addition, such devices apply a single ligatureknot, requiring the user to use more than one device in cases where twoor more knots are applied during a given procedure.

Surgical closure with U- or V-shaped clips is a relatively fast and easymethod to ligate tubular tissue structures and does not require a highlevel of effort or skill from a surgeon, however, incomplete closure andthe possibility of dislodgment and misplacement is inherent to thismethod. Metal pieces can be left inside the body resulting in injury andinterference with CT, MRI and X-ray imaging. In addition, the method canonly be used for tubular tissue structures with a diameter of up to 6 or7 mm.

Surgical closure with stapling techniques offers the advantages of speed(closure in 30 to 60 seconds) as well as simultaneous dissection andligation (occlusion). Safety problems with use of staples for surgicalclosure have been acknowledged by the FDA. Adverse events includeinadequate closure which can lead to bleeding or internal contentleakage due to a discrete line of staples, mismatch of location, tissueruptures by staple bending, the wrong type of staple closure, and/or adisparity between staples and tissue thickness. If a ligature is undertightened, the tubular structure may leak. If a ligature isovertightened, tissue damage may result. In addition, an excessivenumber of staples in a cassette may lead to dropping unused ones insidethe body. In addition, staples can extend beyond the tissue structurebeing ligated and cause penetration of neighboring tissue. Tissue damagemay also occur due to staples left in the body which can also interferewith CT, MRI and X-ray imaging.

The cartridges disclosed herein address the deficiencies in currentlyavailable devices by providing a cartridge that can be employed by asingle user with little to no training for safe, fast, consistentdissection and ligation of tubular tissue structures. The cartridgeprovides for adjustment to the diameter of the tissue structure to beligated (small or large), has no foreign objects to leave behind in thebody, and does not damage surrounding tissue.

In using the cartridge, various embodiments of which are disclosedherein, the compression members or jaws 11 of a grasping or clampingimplement 10 functions to limit or stop any movement of the tubulartissue structure 1 after it is grasped or clamped. A ligature loop 6 ispulled such that it slides over the dissected end of the tubular tissuestructure and is placed at the desired distance from the dissected endcreating a stump 5 of a chosen size. See FIG. 1. The cartridges andmethods disclosed herein stabilize both the ligature loop and thetubular tissue and provide for placement of the knot in the desiredlocation. One cartridge may be used to apply one or more ligature knots.

Cartridge Embodiments

As shown in FIG. 2, the relationship between the size of the ligatureand the size of the tubular structure to the angle (α) of the slantededge of the cartridge relative to the longitudinal axis of thecartridge. If M is the width of the implement, N is the distance fromthe distal edge of the implement to the knot position, K is the lengthof the extended end of the implement, S is the diameter of the tubularstructure, and L is the size of the loop, then the following formulaapplies:

α=arctg((N−M/2)/(S+K))

L=(S+K)/Cos α

In one embodiment, the sleeve 7 of the cartridge 16 can be any shape solong as it fits over the surgical instrument 17, e.g., a clamp, used fora given procedure. The sleeve has opposed proximal and distal ends and awedge-shaped (slanted) distal edge that tapers inwardly. The size andshape of the cartridge sleeve 7 may be varied and correlates with theangle of the slanted edge relative to the longitudinal axis of thesleeve and the desired length of the stump 5.

The slanted edge at the distal end of the cartridge 16 is at an angle ofless than 90° and greater than 10°, for example 80-90°, 75-85°, 70-80°,65-75°, 60-70°, 55-65°, 50-60°, 45-55°, 40-50°, 35-45°, 30-40°, 25-35°,20-30°, 15-25°, 10-20° relative to the longitudinal axis of the tubularstructure 1. The size and shape of the sleeve 7 is variable and thesleeve is designed such that the angle of the slanted edge of the sleeve7 relative to the longitudinal axis of the tubular structure 1 resultsin placement of the ligature yielding a stump 5 having the desiredlength. See FIG. 2.

One embodiment of a cartridge for ligating a tubular tissue structure 1is shown in FIG. 3. In this embodiment, the cartridge has a sleeve 7that fits over the mid longitudinal axis of a grasping or clampinginstrument 10 having jaws 11 that compress the tubular structure asshown in FIG. 4. In this embodiment, the distal end of the sleeve 7 hasa slanted edge and a groove 18 for holding at least one ligature. Theligature has a loop 6 at one end secured by a partially tightenedslidable knot 26. In this embodiment, the sleeve 7 can be placed around,or be attached to the mid-longitudinal axis or the distal end of anyinstrument 17 effective to grasp or clamp a tubular tissue structure 1to be ligated.

FIGS. 5 and 6 illustrate one cartridge embodiment wherein twoindependent grasping or clamping instruments 10 with distal jaws 11 areclamping a tubular structure 1. In FIG. 5, a cartridge has a sleeve 7that fits over the mid longitudinal axis of one of the grasping orclamping instruments 10 which is in a proximal locked position 9. Inthis embodiment, the cartridge is used with an independent cuttingimplement 12 (a scalpel). Some exemplary grasping or clampinginstruments 10 for use in this embodiment include clamps, forceps, ahemostat, an endoscopic clamp, a laparoscopic tool, and the like. Thecartridge 16 is typically disposable and may comprise grasping orclamping implements 10 or be used with reusable or partially reusablegrasping or clamping instruments.

The ligature loop may have a pulling component, for example a ring,attached to the proximal end of the ligature which can slidably move theligature loop thereby tightening the partially tightened slidable knot26 around the tubular structure. See FIG. 6, which also illustrates acartridge in the distal unlocked position 14.

The cartridge may comprise a single barrel or sleeve or two barrels orsleeves. In one embodiment, the cartridge comprises two barrels as shownin FIG. 7. The barrels may have a slanted edge at the distal end 19 andcan be placed around or be attached to the mid-longitudinal axis or thedistal end of any instrument 10 effective to grasp or clamp a tubulartissue structure 1. In single barrel embodiments, the barrel or sleeve 7may be on the right or left side to accommodate different users. Whenthe cartridge comprises two barrels or sleeves 7, it may be used withtwo grasping or clamping instruments 10 that are the same or different.In such cases, a tubular tissue structure 1 may be grasped or clamped oneach side of a location to be dissected or cut, after which the tissueis cut and a ligature loop 6 is placed over each side of the dissectionsite such that a partially slidable knot 26 is tightened at a selectedlocation on each side to yield a stump 5 having the desired length.

In some embodiments, the cartridge 16 has a grasping or clampingimplement 10 at the distal end with jaws 11 for clamping a tubularstructure 1 with ligature loops 6 in a groove 18 at the distal end ofthe cartridge 16, as shown in FIG. 8B. When the cartridge 16 isactuated, one or more ligature loops 8 are pulled and moved out of thedistal groove 18 such that they are in position for a partially slidableknot 26 to be tightened around the dissected end of a tubular tissuestructure 1 as shown in FIG. 8C.

In some embodiments, the cartridge is elongated as shown in FIG. 8A. Thecartridge 16 may be sterile and can be inserted through a trocar 43 fora single use during laparoscopic surgery. An elongated cartridge may beprovided in one or more pieces or sections. In some embodiments, suchelongated single-use sterile cartridges are attached to a handle 21prior to use as shown in FIGS. 10A and 10B. The handle may be reusableor disposable and typically comprises an internal actuation mechanism.In some embodiments, the cartridge 16 and/or the handle 21 comprises atrigger or actuation engager 22 linked to an actuation mechanism 24 formoving the cartridge 16 from a proximal locked position 9 to a distalunlocked (engaged) position 14 before a ligature loop 6 can be pulled.In some embodiments, a surgeon or other user can manually extend andretract the cartridge 16. For example, a switch, trigger or button 22 incommunication with a locking assembly may be used to cause the lockingassembly to release allowing one or more ligatures to be moved.

In some embodiments, a locking assembly, e.g., a cooperating lockingassembly maintains the cartridge in a proximal locked position 9 andcomprises a release or actuation mechanism 24 which when actuated movesthe cartridge to a distal or unlocked position 14. The locking assemblyrelease may be manual or automatic and may comprise a mechanism suchthat the cartridge can be extended or retracted mechanically and/orelectrically. FIG. 10B shows an exemplary handle 21 attached to acartridge 16 via a simple cartridge/handle interface 23 that has aninternal actuation mechanism 24 linked to a spring 25 and a handletrigger or actuation engager 22.

In some embodiments, the cartridge is an “external” cartridge. As shownin FIG. 11B, the distal end of the external cartridge 41 has a groove 18that can house one or more ligature loops 8, and a grasping or clampingimplement 10 with jaws 11 clamping a tubular tissue structure 1. Thefigure also illustrates an exemplary tensioner mechanism 33. In someembodiments, the cartridge comprises a mechanism that adjusts theligature/ligature loop tension by way of a compensator/tensionermechanism that prevents excessive or insufficient tightening forces inorder to achieve appropriate occlusion of each tubular tissue structure.The tensioner mechanism may comprise a spring 32 and may pivot such thatdifferent tension is applied to the ligatures on opposites sides of adissected tubular structure. The tensioner may be adjustable ornon-adjustable. If adjustable, the tensioner mechanism may be automatic.One or more ligature loops (1, 2, 3, 4, 5, 6, 7, 8, 9,10, 11, 12, 13,14, or more) may be installed in the cartridge, and each loop can beselected and tightened by an individual tensioner mechanism. By way ofexample, in some embodiments, the cartridge is equipped (pre-loaded)with 2 to 4 or more ligatures. There may be 1, 2 or more ligatures oneach side of the cartridge, for example in the following combination(1+1); (1+2 or 2+1), or (2+2). Ligatures made of the same material withthe same diameter, may have differences in stretch ability, strength ofligature material and strength of the knot, which can lead to uneventightening of the ligature loops. In such cases, the tensioner mechanismwill compensate for differences in the ligatures, as well as differencesin the diameter and compressibility of the tubular tissues structuresbeing ligated.

In some embodiment, the cartridge or an attached handle comprises anactuating mechanism and the cartridge operates according to thefollowing process: (1) a tubular tissue 1 is compressed with the jaws 11of a grasping or clamping implement 10, (2) the actuator 24 istriggered, (3) the cartridge tensioner 33 (e.g., a tensioner ring)adjusts the compression force to apply the appropriate amount of tensionto each side of the intended dissection point, (4) the knife or blade 13moves towards the distal end of the cartridge 19 and dissects thetubular tissue structure 1, (5) ligature loop(s) 8 are pulled andreleased from the knot holder 34 allowing them to move forward over thedistal end of the clamping jaws 11, tightening the loops/ligatures 8,and (6) free ends of ligature are cut 29 to yield knot ears 4 and astump 5 having the desired length. FIG. 11C illustrates the distal end19 of an external cartridge 41 in an embodiment where followingactuation, the jaws 11 of a grasping or clamping implement 10 haveclamped a tubular tissue structure 1, and it has been dissected. Asingle ligature loop 6 with a partially slidable knot 26 has been pulledand released from a knot holder 34, moved forward and is in position forthe knot to be tightened around the dissected end of the tubular tissuestructure. The knot holder 34 and tensioner ring 33 are shown in moredetail in FIG. 11D, and the ligatures loops 8 in a distal cartridgegroove 18, an exemplary blade 13 for dissecting a tubular tissuestructure, a partially slidable knot of a ligature loop 26, a blade, anda proximal ligature tail 28 are shown in FIG. 11E. The blade 13 may havecutting edges directed proximally or distally.

In some embodiments, the cartridge is an “internal” cartridge. As shownin FIG. 11A, the internal cartridge 40 has one or more ligature loops(each having a partially slidable knot), pre-positioned (“pre-loaded”)in the cartridge 16 or 17, and a central slot or guide 30 for a cuttingimplement such as a blade or knife. As shown in FIG. 12A, the internalcartridge 40 has a wing 35 at the distal end 19 holding one or moreligature loops 8 adjacent the cartridge, each ligature loop having apartially slidable knot 26 and a proximal ligature tail 28. The internalcartridge 40 also has a blade, knife or other cutting implement 13 in acentral slot or guide 30 of the cartridge. In some embodiments, aninternal cartridge 40 is housed in a sleeve and as shown in FIG. 12B,and the blade 13 may have a serrated cutting edge directed distally suchthat it is positioned to move forward toward the distal end of thecartridge to cut (dissect) the tubular tissue structure. FIG. 12Cillustrates the distal end 19 of an internal cartridge 40 in anembodiment where following actuation, the jaws 11 of a grasping orclamping implement 10 have clamped a tubular tissue structure 1, and ithas been dissected. One or more ligature loops 8 have been pulled andreleased from a knot holder 34, and moved forward to a position suchthat the knot of each ligature can be tightened. The next step inoperation of the internal cartridge is shown in FIG. 12D, where a blade,knife or other cutting implement slidably disposed in a central slot orguide of the cartridge has dissected or cut a tubular tissue structureand one or more ligature loops having partially slidable knots arepositioned on the outside of the internal cartridge with wings releasedsuch they can be pulled over the dissected ends of the tubular tissuestructure and pulled to tighten the knots.

In some embodiments, the cartridge is attached to a handle which may besqueezed (engaged) one time to dissect the tubular structure, andsqueezed (engaged) again to release one or more ligature loops from theknot holder and pull the ligature loop over the top of the cartridge,pulling and tightening the ligature loop to generate a knot around thetubular structure that was dissected. In this embodiment, by squeezingthe handle, the user engages the cartridge and initiates a slidingaction such that ligature loops can move over the distal end of thecartridge and be tightened around the stump or stumps created by thedissection, resulting in a knot or knots in the desired location withthe correct amount of tension. In some embodiments, he cartridgecomprises 2 plates and wings that hold the ligature loops in place. Insome embodiments, the cartridge may provide and tighten ligature loopson one side of the dissection point or provide and tighten ligatureloops on both sides of the dissection point. In some embodiments, theinternal cartridge comprises a movable flat plate with flexiblewings/holders/plates and/or positioning grooves for ligature loops. Theblade moves in a central slot or guide inside the cartridge and stops atthe distal end of the cartridge, so the blade is never exposed beyondthe distal end of the jaws.

In some embodiments, the cartridge has an articulating grasping orclamping head 39 at the distal end of the cartridge 19, such that thejaws 11 can be rotated to be at the optimal angle for dissection andligation of the subject tubular structure. (See FIG. 13.)

In some embodiments, the cartridge may be disposable, sterile and used asingle time. In one embodiment, elongated, single-use sterile cartridgesare provided in sterile packaging for use in laparoscopic procedure andthe size of the elongated cartridge may be chosen to fit the trocar thatis used for a specific laparoscopic procedure, e.g., 12 mm, 10 mm, 8 mm,7 mm, 5 mm, and the like. Current devices available for ligation duringlaparoscopic surgery are not disposable and suffer from issues includinga lack of sterility and damage to the reusable elongated arm. Inaddition, currently available laparoscopic devices can ligate, however,they are not capable of also dissecting a tubular tissue structure.Hence, in current laparoscopic procedures, a different device orcomponent must be used for dissection than the device or component usedfor ligation.

In some embodiments, the cartridge comprises an actuation mechanism formoving the cartridge from a locked position to an engaged positionbefore a ligature loop can be pulled. In some embodiments, a surgeon orother user can manually extend and retract the cartridge. For example, aswitch, trigger or button in is communication with a locking assemblysuch that movement of the switch, trigger or button is effective tocause the locking assembly to release allowing the ligature to be moved.In some embodiments, a locking assembly, e.g., a cooperating lockingassembly maintains the cartridge in a proximal locked position 9 andcomprises a release or actuation mechanism which when actuated moves thecartridge to a distal or unlocked position 14. The locking assemblyrelease may be manual or automatic and may comprise a mechanism suchthat the sleeve can be extended or retracted mechanically and/orelectrically. FIG. 8C shows a ligature loop that has been pulled andmoved out of the distal groove such that it is in position for apartially slidable knot to be tightened around a dissected end of atubular tissue structure.

A single cartridge may hold one or more ligature loops. The ligatureloops may be preloaded into a single groove on top of one another oradjacent one another, or each ligature loop may be in a separate groove.A groove 18 may hold more than one ligature loop 6, e.g., side-by-sideor one top of one another. The groove may be on the inside or outside ofthe cartridge. In embodiments where there is more than one ligatureloop, each ligature loop is independently tightenable and the ligatureloops are released one at a time from the groove of the cartridge. Thegroove of a cartridge may hold from 1 to 5, 1 to 10, 1 to 15, 1 to 20, 1to 25, 1 to 30, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16,17, 18, 19, 20, 21, 22, 23, 2, 25, 26, 27, 28, 29 or 30 ligature loops,wherein each ligature loop is independently tightenable. One or moreligature loops may be pulled at the same time. Ligature loops may betightened by pulling them around the side(s) or over the top of thecartridge.

In some embodiments, the jaws of a grasping or clamping implement of acartridge are used to compress a tubular tissue structure before it isdissected. In some embodiments, the grasping or clamping implement isused to compress a tubular structure that was previously severed or cut,for example in an accident or during a surgical procedure. In eithercase, the cartridge disclosed herein may be used to place and tighten aligature knot around the tubular structure.

In some embodiments, the cartridge comprises a knot holder located onthe sleeve wherein the knot holder has a locked position and comprises arelease which when actuated allows a ligature to be pulled. The knotholder may hold one or more knots, wherein one knot is released eachtime the knot holder release is actuated.

The cartridge may be made from any medical grade material, for example amaterial that is or can be FDA approved for use in a medical device. Thematerial may be one or more of pliable, soft, rubbery or rigid and maybe made by any method. Exemplary materials include but are not limitedto silicone, resin-reinforced silicone, partially crosslinked elastomers(e.g. gels), resins and metal.

Ligatures

Any type of ligature (also referred to as a “suture”) can be used in thecartridges and methods disclosed herein, independent of material,stiffness, diameter and other characteristics. The ligature may compriseany suture material including dissolvable (absorbable) ornon-dissolvable (non-absorbable) suture material or metal wire. Varioussized knotting elements can be used and ligatures with differentdiameters can be used to complement a particular sized knotting elementand/or a particular procedure. The ligature can be flexible to allow itto be manipulated and bent as needed, and can have a stiffness thatallows it to retain a certain configuration once moved into thatconfiguration and the stiffness of the ligature can be such that whenpushed through the knotting element (or partially slidable knot) toadjust and/or enlarge the size of the loop of the ligature, it does notcollapse. The ligature can be biocompatible and/or bioresorbable, andcan be formed of any material known in the art for forming a knot toligate a tubular structure inside the body of a human or animal.

Ligatures may be monofilament or braided and of any size appropriate tothe procedure being conducted. The size of ligature material is measuredby its width or diameter and is vital to proper tubular tissue ligation.Monofilament ligatures are usually non-absorbable. Braided ligatureusually may cause a greater inflammatory response; however, they requirefewer ties to maintain the knot integrity. These include silk, cottonand polyester fibers. Ligatures may be absorbable or non-absorbable.Absorbable ligatures are made of materials which are broken down intissue after a given period of time. Absorbable ligatures may benatural, e.g., catgut, or synthetic, e.g., polymer fibers, which may bebraided or monofilament. Natural absorbable ligatures may be plaincatgut or chromic catgut and synthetic absorbable ligatures include, butare not limited to polyglycolic acid ligatures, polyglactin ligatures(pgla ligatures), poliglecaprone ligatures (monocryl) (pgcl ligatures),and polydioxanone ligatures (pds). Non-absorbable ligatures include butare not limited to natural fiber, silk, and artificial fibers, such aspolypropylene, polyester or nylon, and stainless steel wire.

Ligature Knots

An adequate closure of a dissected end of a tubular tissue structure isvital to minimize surgical site bleeding and infection. A knot shouldsecure the tissue and be simple, easy, quick and reliable. A good knotmust be properly formed so the ligature does not slip or cut intoitself, and must be easily tightened to ensure maximum strength. Theknot must resist slippage when a load is applied to it and must maintaina tight ligature loop as a knot is tied.

Compound sliding knots have more than one turn of the wrapping strand,for example, any sliding knot other than a half hitch. It is preferredthat a knot is partially tightened with a ligature loop that slidessmoothly and freely without unraveling, jamming prematurely or cuttingthrough tissue as it slides.

Many sliding knots may be used in the cartridges and methods describedherein, including but not limited to a Duncan loop, Nicky's knot ortaut-line hitch, a surgeon's knot, a Tennessee slider, Roeder's knot, anSMC knot, a Weston knot, Meltzer's knot, Tayside knot, two half-hitches,reversed half-hitches, a practical knot (simple or advanced version), agiant knot, a modified taut line hitch, a clinch knot, a secure knot,Mishra's knot, a blood slipknot, a Hangman's knot, a Hangman's tie, anda combination or variant thereof. See, e.g., Akindele et al., 2014,WJOLS, 7(1) 28-32.

Ligature loops and sliding knots for use in the cartridges and methodsdisclosed herein must be capable of being handled in a stable manner toencircle and close around a tubular structure in a precise and accuratemanner resulting in effective ligation and the desired stump length. Oneor more knots may be applied to a tubular structure using a singlecartridge and methods disclosed herein. Ligatures comprise a slidingloop and can be single, double or triple. A ligature is pulled to placethe knot around the tubular structure to be ligated. In someembodiments, the pulling force used to tighten the knot is adjustableusing software. In other cases, the pulling force used to tighten theknot is applied manually.

Dissection and Cutting Implements

In some embodiments, the device is used only for ligation, e.g., in thecase of trauma, where the device provides a means to quickly ligate atubular structure (i.e., a blood vessel) that has been severed.

In general, the cartridge comprises a blade or knife and is used fordissection and ligation. In such embodiments, the cartridge includes ablade or knife, for example, a single use, disposable blade or knife.This provides advantage over currently available options, such assterility and time savings.

In some embodiments, the cartridge comprises a guide for a cuttingimplement such as a blade or knife that slides within the guide into thecutting position, but cannot extend beyond the distal end of thecartridge. The knife or blade is actuated when it is engaged. Suchactuation may be manual or automatic. Blades, knives and other cuttingimplements for use in the cartridge may have any shape and cutting edgethat is effective to dissect the tubular tissue structure of interest.Examples include, but are not limited to, spear-shaped, curved orrounded, dovetail-shaped, flat, concave, convex, double-edged, singleedged, having teeth, and serrated blades, knives and other cuttingimplements.

Methods

The cartridges described herein may be used in any surgical procedure.For example, the cartridge may be used in minimally invasive surgery,open surgery, laparoscopic, robotic, or endoscopic procedures.

In some embodiments, the methods may be used to ligate any animal orhuman tubular tissue structure by carrying out the steps of constrictingand thus stabilizing the tubular tissue structure with the jaws of agrasping or clamping implement prior to ligation, slidably engaging ablade or knife moving it through a central guide or channel to thedistal end of the cartridge such that the blade or knife dissects orcuts the tubular tissue structure resulting in dissected ends, pullingthe proximal end of one or more ligature loops, releasing them from thecartridge such that when the ligatures move over or around the distalend of the cartridge and over the dissected end of the tubular tissuestructure, they can tighten a partially tightened slidable knot aroundthe dissected ends of a tubular tissue structure resulting in a knot andgenerating a stump of the desired length. After the ligature is pulledand the knot is tightened, the method may further comprise cutting theproximal tail of the ligature generate a ligature end or knot ear usingany cutting implement effective under the circumstances. All the stepsof the method may be carried by a single user.

Utility

The cartridges and methods disclosed herein can be used to ligate anytubular tissue structure within the human or animal body. Some examplesinclude blood vessels, lymph vessels, portions of the digestive tract,fallopian tubes, colorectal and other polyps, cancerous and otherdiseased tissue, portions of the digestive tract, the appendix, the gallbladder, the trachea, and the spleen.

More specifically, exemplary procedures wherein the cartridge of theinvention may be employed are general surgery, including but not limitedto, appendectomy (closure of appendix and mesentery), cholecystectomy(closure of cystic artery and duct), splenectomy (closure of splenicvessels), pancreatic duodenal resection (closure of common bile duct andartery); urology, e.g., nephrectomy (ligation of ureter and renalvessels); varicocoelectomy (closure of testicular veins); gynecology,e.g., tubectomy and adnexectomy and female sterilization (closure offallopian tubes), and robotic surgery.

Robotic systems may be used to aid in surgical procedures. In someembodiments, the cartridges described herein are attached to surgicalrobots by way of a simple attachment.

Endoscopic surgery makes use of a natural orifice and is often used inremoval of polyps and other cancerous or diseased tissue. In oneembodiment, the cartridge and methods are used for endoscopic surgery,for example in the dissection and ligation of polyps or cancerous ordiseased tissue in any of a number of locations. An exemplary elongatedcartridge for use in removal of polyps is shown in FIG. 9.

In one exemplary aspect of this embodiment, the cartridge is used in amethod for removal of polyps in the digestive tract. In this embodiment,an appropriately sized cartridge may be provided on or attached to anelongated flexible conduit, e.g., a flexible endoscope, that extendsfrom outside the subject through a natural orifice into and along atleast a portion of the digestive tract to a target location in thedigestive tract. The distal end of the elongated flexible conduit mayattach to a cartridge, e.g., an elongated cartridge comprising agrasping or clamping implement.

Current methods for removal of a polyp involve placement of a ligatureloop over a polyp which is a difficult procedure when carried out insidea tubular structure in the body. Many current methods for poly removaldo not include the step of ligation prior to cutting the polyp resultingin excessive bleeding that is often stopped by ablation which damagesadjacent tissue uses well as the tissue that has been cut.

Kits

In some embodiments, a kit is provided that includes a single usesterile cartridge. The kit may also comprise one or more of: (a)ligatures which may be pre-loaded in the cartridge or providedseparately; (b) one or more disposable blades or knives; (c) anattachment to increase the length of the cartridge; and (d) a single useor disposable handle. The ligatures may each have partially tightenedslidable knots. Each of components (a)-(d) may also be provided induvialin sterile packaging. In some embodiments, a reusable handle is includedin the kit.

1-28. (canceled)
 29. A device for cutting and ligating tissue, thedevice comprising: an elongate cartridge body having a radial periphery,and a proximal end and an opposite distal end, the proximal end and thedistal end defining a cartridge axis; a cartridge-base interface at theproximal end, the cartridge-base interface arranged to couple the deviceto a base that includes an actuator operative to move the device from anon-deployed configuration to a deployed configuration; a deployablegrasping or clamping implement housed within the cartridge body when thedevice is in the non-deployed configuration, the deployable grasping orclamping implement having jaws situated proximate the distal end; adeployable cutter assembly housed within the cartridge body when thedevice is in the non-deployed configuration, the deployable cutterassembly including a blade movable relative to the cartridge body alonga guide or channel that is arranged along the cartridge axis; a firstligature loop holder fixed to the cartridge body and arranged to retaina first section of a ligature loop to extend along a portion of theradial periphery; and a second ligature loop holder fixed to the cutterassembly and arranged to retain a second section of the ligature loop topass through an interior of the cartridge body and to be movablerelative to the first section along the cartridge axis; wherein thedeployable grasping or clamping implement is actuatable to grasp orclamp the tissue, and the deployable cutter assembly is actuatable tomove the blade relative to the cartridge body to cut the tissue tothereby form a pair of cut ends, and to extend the ligature loop betweenthe cut ends.
 30. The device of claim 29, wherein the ligature loopfurther includes a proximal tail and a partially tightened slidableknot, and wherein the device further comprises: a tensioner operative totighten the ligature loop by pulling the proximal tail through thepartially tightened slidable knot.
 31. The device of claim 29, whereinthe non-deployed configuration comprises a proximal locked positionwherein the ligature loop is non-tightenable, and the deployedconfiguration comprises an unlocked position wherein the ligature loopis tightenable.
 32. The device of claim 29, wherein the deployablegrasping or clamping implement and the deployable cutter assembly areeach actuatable via the cartridge-base interface.
 33. The device ofclaim 29, wherein the first ligature loop holder includes a grooverecessed in an exterior surface of the cartridge body and elongatedalong a circumferential direction.
 34. The device of claim 29, furthercomprising: a third ligature loop holder fixed to the cartridge body andarranged to retain a third section of a second ligature loop to extendalong a portion of the radial periphery; and wherein the second ligatureloop holder is further arranged to retain a fourth section of the secondligature loop to pass through an interior of the cartridge body and tobe movable relative to the third section along the cartridge axis. 35.The device of claim 29, wherein the first and the second loop holdersare each arranged to hold a plurality of sections of a correspondingplurality of ligature loops.
 36. The device of claim 29, furthercomprising: a knot holder operative to prevent the ligature loop havinga partially tightened slidable knot from being pulled when the device isin the non-deployed configuration.
 37. The device of claim 29, furthercomprising a plurality of ligature loops installed in the first ligatureloop holder and the second ligature loop holder.
 38. The device of claim37, wherein each ligature loop of the plurality of ligature loops isindependently tightenable.
 39. A device for dissecting and ligating atubular tissue structure comprising the device according to claim 29,and further comprising the base.
 40. The device of claim 39, wherein thebase comprises a handle and a trigger.